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CED EU INFO 2015/03

Issue 3 - August 2015



Regulation on European Professional Card and alert mechanism published

Implementing regulation for the European Professional Card (EPC) and alert mechanism under the Professional Qualifications Directive (2005/36/EC) have been published in the EU Official Journal. By 18 January 2016 competent authorities will need to put in place a process to grant recognition of professional qualifications to nurses, pharmacists and psychotherapists (in addition to mountain guides and real estate agents) by issuing an EPC. Doctors were initially also expected to in the first group of professions to be issues EPCs but have later been excluded. The second wave of implementation is expected to follow in 2018 at the earliest.   Read more

European Commission to evaluate EU Action Plan on antimicrobial resistance

In July the European Commission published a roadmap on the Evaluation of the Action Plan against the rising threats from Antimicrobial Resistance (AMR). The Commission noted that despite many international initiatives the situation was getting worse.  The purpose of the evaluation is to produce an evidence based report to assess the impact of the implementation of the EU Action Plan on AMR, specifically to analyse whether the 12 key strategic actions contained in the Action Plan were the most appropriate actions to be taken to combat AMR, which elements worked well or not, if the objectives are still relevant to the needs in tackling AMR and if the approach was holistic. As the Action Plan will expire in 2016, the results of this evaluation will provide the Commission with the basis to make informed decisions on what new or additional policy measures should be taken in the medium and long term strategy to combat AMR in the European Union and globally.

Progress on data protection regulation

Following the agreement of the Council on a general approach to the General Data Protection Regulation on 15 June, trialogue negotiations on the regulation between the Council, the Parliament and the Commission started on 24 June. Eight meetings have been scheduled between July and September with the goal of concluding the discussions by the end of the year. While negotiators appeared optimistic in their public statements, differences have been noted in their respective positions on the rights of consumers, duties of data controllers, explicit consent and incompatible further processing.   Read more

Further technical work needed on Medical Devices Regulation

On 19 June, the Council agreed on the substance of its approach to the medical devices and the in-vitro medical devices regulations and asked its preparatory bodies to finalise the outstanding technical work on the preambles of the two directives. Once this is done, the Luxembourg Presidency will be given the necessary mandate to start the trialogue negotiations with the Parliament and the Commission. Further information and the Council's text are available here

Cross-border healthcare Directive evaluated

In May the European Commission published an evaluative study of the Cross-border healthcare directive (2011/24/EU). The study concluded that there was still "immense potential to grow in the years ahead" in connection to the Directive which was supposed to have been transposed into national legislation by 25 October 2013. For instance, citizens are not adequately informed about the opportunities available to them under the Directive and may be prevented by administrative burden concerning prior authorisation from seeking healthcare abroad. Quality and safety do not seem to be determining factors in patients' decisions. The study is available here. Meanwhile, the Luxembourg Presidency has announced that it would put the functioning of the Cross-border directive on the agenda of the Health Ministers' informal meeting on September 24 and 25.  

New opinion and mandates for the Expert Panel on effective ways on investing in health

On 29 July, the Expert Panel on effective ways of investing in health, a multi-sectorial independent body set up by the European Commission in 2013, issued a non-binding opinion on cross-border healthcare cooperation in the EU. The panel noted that there is scant knowledge of the scale of cross-border movement of patients and that immediate steps should be taken to collect relevant data. And while discussions about cross-border collaboration currently take place in many different and often fragmented fora, it might be beneficial to bring all parties involved together to address the overall situation.   Read more

Tobacco consultations

Based on the Tobacco Products Directive (2014/40/EU), two consultations have been launched. A targeted stakeholder consultation on traceability and security features ran until 31 July and was based on options identified by the feasibility study published in May. The CED replied to the consultation and supported option 2 identified in the feasibility study (a third party operated solution, with direct marking on the production lines carried out by a solution or service provider). A further public consultation on tobacco additives is open until 6 September. 

TTIP negotiations update

The latest, 10th round of the Transatlantic Trade Investment Partnership (TTIP) took place in Brussels between 13 and 17 July. A report from the European Commission states that the "talks covered a broad range of subjects across the three TTIP pillars" and that the next round will take place in the United States in the third quarter of 2015.

In response to criticism that the TTIP negotiations were not taking into account civil society concerns, the European Commission also organised a stakeholder event on 15 July. During the event stakeholders were invited to present their views on TTIP to the EU and US negotiators and were briefed on the progress of negotiations. The CED was not able to attend the event but sent a written message to the chief EU negotiator, stressing its position on TTIP as adopted during the CED General Meeting in May


Report on consultation on endocrine disruptors published

On 24 July, the European Commission published a summary report of the replies to the public consultation on scientific criteria to identify endocrine disruptors under the regulations on biocidal and plant protection products. The consultation ran between September 2014 and January 2015 and the results will feed into the ongoing Impact Assessment that will be concluded in 2016. The decision on the criteria for endocrine disruptors, chemicals that interfere with hormone systems and may affect health and environment is expected to be taken in 2016 at the earliest. The summary report is available here.


EPHA conference: Towards a European Union for Health - From Health in All Policies to EU Governance for Health and Well-Being?

On 2 and 3 September in Brussels. More information is available here.

eHealth Stakeholder Group

On 10 September in Brussels.

For more information contact:
CED Brussels Office
Tel: + 32 2 736 34 29

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